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Neurobiol Aging. 2011 Dec;32 Suppl 1:S64-6. doi: 10.1016/j.neurobiolaging.2011.09.008. Epub 2011 Oct 8.

Clinical trial methodologies for disease-modifying therapeutic approaches.

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  • 1Department of Neurosciences, University of California San Diego, La Jolla, CA 92093, USA.


In recent years, advances in Alzheimer's disease (AD) biomarker research have provided powerful tools to improve trial design. In particular, biomarkers provide powerful methods for the selection of individuals with Alzheimer's disease prior to the onset of dementia. Data suggest that neuroimaging biomarkers will be useful as endpoints for trials in very early, even asymptomatic disease, though further work is necessary to establish validity for regulatory purposes.

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